Selective Serotonin Reuptake Inhibitor
Escitalopram for Anxiety
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience, Cincinnati, OH
EscitalopramPhase 4RecruitingLed by Laura B Ramsey, PhDResearch Sponsored by University of CincinnatiEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID
Clinical Global Impressions-Severity (CGI-S) score ≥4 at Visits 1 & 2
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to week 12/early termination
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved
Study Summary
This trial will test whether a person's metabolism affects how they respond to the drug escitalopram. 132 people will be given the drug and monitored for 12 weeks.
Eligible Conditions
- Anxiety
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with generalized, social, and/or separation anxiety disorder according to specific criteria.
Select...
Your overall level of symptoms is rated as moderate to severe by the doctor during two visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12/early termination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12/early termination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pediatric Anxiety Rating Scale severity score
Secondary outcome measures
Tolerability-Activation
Side effects data
From 2019 Phase 4 trial • 115 Patients • NCT0190200423%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Diarrhea
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard dosingExperimental Treatment1 Intervention
Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.
Group II: Pharmacogenetically-guided escitalopram dosingExperimental Treatment1 Intervention
Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
FDA approved
Find a site
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,903 Previous Clinical Trials
2,198,823 Total Patients Enrolled
7 Trials studying Anxiety
4,794 Patients Enrolled for Anxiety
University of CincinnatiLead Sponsor
401 Previous Clinical Trials
621,502 Total Patients Enrolled
6 Trials studying Anxiety
692 Patients Enrolled for Anxiety
Laura B Ramsey, PhDPrincipal Investigator
Children's Mercy Kansas CityJeffrey R Strawn, MDPrincipal Investigator
University of Cincinnati1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Anxiety
60 Patients Enrolled for Anxiety
Jeffrey R. Strawn,, MDPrincipal Investigator
University of CincinnatiLaura B. Ramsey, PhDPrincipal Investigator
Children's Hospital Medical Center, CincinnatiMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions within this investigation for participants?
"Affirmative. Clinicaltrials.gov indicates that the trial, which was initially advertised on March 8th 2021, is currently enrolling participants. 132 individuals from 1 clinical site are being sought for this research program."
Answered by AI
To what extent could Escitalopram be detrimental to individuals?
"Based on the Phase 4 status of Escitalopram, our team at Power assigned a score of 3 to its safety rating. This drug has already been approved for patient use."
Answered by AI
What is the upper limit of individuals participating in this clinical experiment?
"Affirmative. Clinicaltrials.gov informs that recruitment for this medical experiment is ongoing, commencing on the 8th of March 2021 and last updated on the 14th February 2022. In total, 132 individuals are required to participate at a single site."
Answered by AI
What qualifications do potential participants need to meet in order to be eligible for this experiment?
"This clinical trial calls for 132 participants, aged between 12 and 17 years old and suffering from an anxiety disorder."
Answered by AI
Are there any prior research studies that have explored the effects of Escitalopram?
"Presently, 23 different clinical trials are researching escitalopram with 5 of those in the final stages. Most of these tests take place in Cincinnati, Ohio though there are 45 distinct sites running this investigation."
Answered by AI
Does this trial encompass participants aged 85 and over?
"This study is open to adolescents aged 12-17. Clinicialtrials.gov has 148 trials recruiting for individuals under 18 and 453 studies looking for participants over 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies